NCT03120897终止不适用
Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Number of subjects in which respiratory rate is collected
研究概览
简要总结
To capture high resolution waveform data and numerical data from investigational and FDA-released RAM sensors in the neonatal, infant, pediatric, and adult patient population
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female subjects that are between 0 to 70 years old.
- •Neonate, Infant, Pediatric, Adult, and Pregnant subjects with fully developed skin.
排除标准
- •Patients with skin abnormalities at the planned application sites that would interfere with sensor, cannula or electrode applications.
- •Patients with pre-existing conditions and/or co-morbidities that would prohibit them from participating in the study due to unacceptable risks to their health and well-being, as determined by the Principal Investigator (PI).
- •Patients who the PI deems ineligible at the PI's discretion
结局指标
主要结局
Number of subjects in which respiratory rate is collected
时间窗: Duration of surgery
Capture high resolution waveform data and numerical data from respiratory rate using RAM sensor
次要结局
未报告次要终点
研究者
研究点 (2)
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